Acular LS

"If you've ever been sleep-deprived, you've probably had a firsthand glimpse of the blood vessels in your eyes. But what you haven't seen—and what many eye care professionals cannot see as well as they would like—are the vessels closes"...

Acular LS

WARNINGS

There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other nonsteroidal anti-inflammatory agents. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs.

With some nonsteroidal anti-inflammatory drugs there exists the potential for increased bleeding time due to interference with thrombocyte aggregation. There have been reports that ocularly applied nonsteroidal anti-inflammatory drugs may cause increased bleeding of ocular tissues (including hyphemas) in conjunction with ocular surgery.

PRECAUTIONS

General

All topical nonsteroidal anti-inflammatory drugs (NSAIDs), including ketorolac
tromethamine ophthalmic solution, may slow or delay healing. Topical corticosteroids
are also known to slow or delay healing. Concomitant use of topical NSAIDS and
topical steroids may increase the potential for healing problems.

Use of topical NSAIDs may result in keratitis. In some susceptible patients, continued use of topical NSAIDs may result in epithelial breakdown, corneal thinning corneal erosion, corneal ulceration or corneal perforation. These events may be sight threatening. Patients with evidence of corneal epithelial breakdown should immediately discontinue use of topical NSAIDs and should be closely monitored for corneal health.

Postmarketing experience with topical NSAIDs suggests that patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases (e.g , dry eyesyndrome), rheumatoid arthritis, or repeat ocular surgeries within a short period of time may be at increased risk for corneal adverse events which may become sight threatening. Topical NSAIDs should be used with caution in these patients.

Postmarketing experience with topical NSAIDs also suggests that use more than 24 hours prior to surgery or use beyond 14 days post-surgery may increase patient risk for the occurrence and severity of corneal adverse events.

It is recommended that ACULAR LS™ (ketorolac tromethamine ophthalmic solution) ophthalmic solution be used with caution in patients with known bleeding tendencies or who are receiving other medications, which may prolong bleeding time.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Ketorolac tromethamine was neither carcinogenic in rats given up to 5 mg/kg/day orally for 24 months (156 times the maximum recommended human topical ophthalmic dose, on a mg/kg basis, assuming 100% absorption in humans and animals) nor in mice given 2 mg/kg/day orally for 18 months (62.5 times the maximum recommended human topical ophthalmic dose, on a mg/kg basis, assuming 100% absorption in humans and animals).

Ketorolac tromethamine was not mutagenic in vitro in the Ames assay
or in forward mutation assays. Similarly, it did not result in an in vitro
increase in unscheduled DNA synthesis or an in vivo increase in chromosome
breakage in mice. However, ketorolac tromethamine did result in an increased
incidence in chromosomal aberrations in Chinese hamster ovary cells.

Ketorolac tromethamine did not impair fertility when administered orally to male and female rats at doses up to 280 and 499 times the maximum recommended human topical ophthalmic dose, respectively, on a mg/kg basis, assuming 100% absorption in humans and animals.

Pregnancy

Teratogenic Effects: Pregnancy Category C

Ketorolac tromethamine, administered during organogenesis, was not teratogenic in rabbits or rats at oral doses up to 112 times and 312 times the maximum recommended human topical ophthalmic dose, respectively on a mg/kg basis assuming 100% absorption in humans and animals. When administered to rats after Day 17 of gestation at oral doses up to 46 times the maximum recommended human topical ophthalmic dose on a mg/kg basis, assuming 100% absorption in humans and animals, ketorolac tromethamine resulted in dystocia and increased pup mortality. There are no adequate and well-controlled studies in pregnant women. ACULAR LS™ (ketorolac tromethamine ophthalmic solution) ophthalmic solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nonteratogenic Effects

Because of the known effects of prostaglandin-inhibiting drugs on the fetal
cardiovascular system (closure of the ductus arteriosus), the use of ACULAR
LS™ ophthalmic solution during late pregnancy should be avoided.

Nursing Mothers

Caution should be exercised when ACULAR LS™ (ketorolac tromethamine ophthalmic solution) ophthalmic solution is administered
to a nursing woman.

Pediatric Use

Safety and effectiveness of ketorolac tromethamine in pediatric patients below
the age of 3 have not been established.

Geriatric use

No overall differences in safety or effectiveness have been observed between
elderly and younger patients.

Last reviewed on RxList: 2/13/2009
This monograph has been modified to include the generic and brand name in many instances.